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Ultra Crave: An Investigation of Ultra-Processed Food

Primary Purpose

Food Addiction

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dietary change (low ultra-processed food)
Dietary change (high ultra-processed food)
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Food Addiction focused on measuring Withdrawal, Food Addiction, Highly Processed Foods

Eligibility Criteria

25 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 25 to 60 years of age English-speaking Must own an Android or iPhone Smartphone Live within a 1-hour radius of the laboratory endorsement of > 4 symptoms on the YFAS 2.0 completed during eligibility screener; at the time of consent, symptom count must remain above threshold for food addiction (this discrepany is based on a previously found tendency during pilot testing to overestimate food addiction symptoms at the time of screening) endorse daily intake of multiple UP foods likes chocolate milkshake (fMRI) willing to follow dietary instructions provided by team willing to come to lab 3 times Exclusion Criteria: participants with a self-reported BMI < 18.5 and > 40 current diagnoses of disorders that can impact reward, metabolic functioning, or the ability to complete the imaging protocol (e.g., seizures, Tourette's, cancer, Irritable bowel syndrome, Inflammatory bowel disease, Hypothyroidism, substance use disorder, ADHD) Type 1 or Type 2 diabetes, pre-diabetes, hypoclycemia history of food allergies or restrictive dietary requirements (e.g., vegan) medications that impact appetite or reward functioning (e.g., anti-psychotic medication, insulin) history of diagnosis of a severe mental illness (e.g., bipolar, schizophrenia, psychotic disorder) a diagnosis of a restrictive eating disorder (anorexia nervosa, bulimia nervosa, purging disorder) within the last 5 years more than a 20-pound weight fluctuation in the last three months prior weight loss surgery (e.g., bariatric surgery) current pregnancy, breast-feeding, trying to get pregnant, or within six months of having given birth high levels of caffeine (i.e., average daily intake over 600mg) intake use of tobacco, nicotine, cannabis products within the past month and/or unwillingness to abstain from these substances during the main portion of the study high-risk alcohol use (based on the AUDIT) high levels of picky eating fMRI contraindications (e.g., claustrophobia, metal implants) red/green color blindness frequent (i.e., weekly) night shift work or irregular shifts and for abnormal sleep patterns (i.e., wake up time after 11am) inability to complete a random report within 90 minutes THC Cannabis within the past week

Sites / Locations

  • University of MichiganRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Low UP Food Diet

High UP Food Diet

Arm Description

Outcomes

Primary Outcome Measures

Withdrawal Symptoms
Withdrawal symptoms (e.g., anger, anxiety) will be assessed using ecological momentary assessment (EMA) on a scale from 1 (not at all) to 7 (extremely); higher scores indicate greater withdrawal symptoms.
Craving of ultra-processed (UP) foods
Craving of UP foods will be assessed using EMA on a scale from 1 (not at all) to 7 (extremely); higher scores indicate greater craving of UP foods.
Low UP food intake
Intake of low UP foods will be assessed using remote food photography method.
Self-Reported Low UP food intake
Intake of low UP foods will be assessed using EMA reports of food intake. Responses will be coded into high and low UP food intake based on the NOVA classification.

Secondary Outcome Measures

Reactivity to a stressor
Stress reactivity will be assessed using an in-lab stress task that has participants listen to an audio recording of a current stressor in their life. Participants' heart rate in response to the audio recording, relative to a baseline measurement, will be used as an indicator of stress reactivity; an increase in heart rate will be indicative of greater stress reactivity.
Self-reported reactivity to a stressor
Stress reactivity will be assessed using an in-lab stress task that has participants listen to an audio recording of a current stressor in their life. Participants' subjective ratings of reactivity will be assessed at baseline (prior to listening to the audio recording) and immediately after listening to the audio recording using the negative affect subscale from the Positive and Negative Affect Schedule (PANAS); each item is rated on a 1 (very slightly or not at all) to 5 (extremely) scale, with higher numbers indicating greater experienced affect; an increase in score, relative to baseline, will indicate greater stress reactivity.
Cue reactivity to a simulated fast food restaurant
Participants will spend 5 minutes in a simulated fast food restaurant. Participants' heart rate in response to the simulated fast food restaurant, relative to a baseline measurement, will be used as an indicator of cue reactivity; increases in will be indicative of greater cue reactivity.
Self-reported cue reactivity to a simulated fast food restaurant
Participants will spend 5 minutes in a simulated fast food restaurant. Participants' subjective craving will be assessed at baseline (prior to entering the restaurant) and while in the restaurant on a scale from 0 (no craving at all) to 100 (I have never craved food more), with greater numbers indicating higher craving; an increase in score, relative to baseline, will indicate greater cue reactivity.
Level of reinforcement value for ultra processed foods
Participants will complete a computerized task that measures their willingness to work (i.e., reinforcement value) for a UP food gift card relative to a non-food gift card.
Magnitude of neural reward-related response to tasting a milkshake
Participants will complete an fMRI paradigm where they see a UP food cue (i.e., picture of a chocolate milkshake) that predict receipt of a UP food (i.e., a chocolate milkshake). The paradigm also includes a control cue (i.e., picture of a water glass) that predicts receipt of a tasteless solution (which contains the ionic components of saliva; 25 mM KCl and 2.5 mM NaHCO3 in distilled water). Participants' activation in neural regions associated with reward (e.g., mOFC, striatum) to the milkshake cue (relative to the water cue) will be used as a measure of increased reward-related response to UP food cues.
Blood Glucose Level
Assessed using a continuous blood glucose monitor.

Full Information

First Posted
August 11, 2023
Last Updated
October 17, 2023
Sponsor
University of Michigan
Collaborators
National Institute on Drug Abuse (NIDA), Oregon Research Institute, University of Tasmania, Brown University, Pennington Biomedical Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT06044285
Brief Title
Ultra Crave: An Investigation of Ultra-Processed Food
Official Title
Ultra Crave: A Biopsychobehavioral Investigation of Withdrawal From Ultra-Processed Food in Humans
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 5, 2023 (Actual)
Primary Completion Date
August 5, 2028 (Anticipated)
Study Completion Date
August 5, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institute on Drug Abuse (NIDA), Oregon Research Institute, University of Tasmania, Brown University, Pennington Biomedical Research Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study experimentally investigates whether a reduction in ultra-processed (UP) food intake (1) causes aversive withdrawal symptoms in humans, (2) increases the motivational salience of UP food cues and, if so, (3) whether these factors undermine the ability to adhere to a low-UP diet. The following aims and hypotheses are tested: Aim 1: To investigate whether aversive physical, cognitive, and affective withdrawal symptoms emerge in response to reduced UP food intake compared to a calorically equivalent high-UP diet, and whether this predicts failure to adhere to a low-UP diet. H1a: Reducing UP food intake will result in aversive physical, cognitive, and affective withdrawal symptoms, as indicated by 1) ecological momentary assessment (EMA) reports of aversive withdrawal symptoms, and 2) heart rate reactivity and subjective distress to an in-lab stressor. H1b: Aversive symptoms of UP food withdrawal will predict greater UP food intake and higher blood glucose levels when trying to adhere to a low UP diet. Aim 2: To investigate whether increased motivational salience of UP food cues emerges in response to reduced UP food intake, and whether this predicts failure to maintain a low-UP diet. H2a: Reducing UP food intake will result in increased motivational salience of UP food cues, as indicated by 1) EMA reports of UP food craving, 2) heart rate reactivity and subjective craving in a simulated fast-food restaurant, 3) heightened reinforcement value for UP food relative to other reinforcers, and 4) greater reward-related neural response to UP food cues. H2b: Increased motivational salience of UP food cues will predict greater UP food intake and higher blood glucose levels when trying to adhere to a low UP diet.
Detailed Description
The study will include a combination of in-person, at-home, and virtual activities over the course of ~22 days (contingent on scheduling, this duration may vary and particularly between in-person visits #1 and #2). Participants complete three in-lab visits, each followed by a week of remote data tasks (e.g., remote food photography, EMA, continuous glucose monitoring, and physical activity and sleep tracking (Fitbit). During in-lab visit #1, participants will complete questionnaires, behavioral tasks, and interviews, and will have body composition measurements taken (height, weight, Inbody scan). Participants will complete the remote tasks for the following week while eating their typical diet (i.e., baseline period). During in-lab visit #2, participants will complete questionnaires, interviews, and body composition measurements (height, weight, Inbody scan). Participants are randomly assigned to a high or low UP food condition and will be provided with food and beverages consistent with their condition, which they are required to exclusively consume during week 2 of remote data collection (i.e., dietary intervention period). During in-lab visit #3, participants will complete questionnaires, behavioral tasks, body composition measurements (height, weight, InBody scan), and an fMRI scan. All participants are provided with dietary instructions for a low UP diet to follow on their own during week 3 of remote data collection (i.e., dietary adherence period). At the end of the third week of remote data collection, participants are asked to complete additional questionnaires, provide information about their current diet, and complete a remote interview about their experience with the study. Participants are contacted 1- and 3-months later to complete a short follow-up survey and provide information about their current diet.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Food Addiction
Keywords
Withdrawal, Food Addiction, Highly Processed Foods

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Multi-method, within subjects, perspectives, experimental design
Masking
ParticipantOutcomes Assessor
Masking Description
Participants and outcome assessors will be blinded to the participants' condition. The study coordinator will oversee the randomization protocol.
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low UP Food Diet
Arm Type
Experimental
Arm Title
High UP Food Diet
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Dietary change (low ultra-processed food)
Intervention Description
This study incorporates within- and between-subject comparisons. All participants complete a series of three in-lab visits with remote data collection: Visit 1 and the following week comprise the baseline assessment period. Visit 2 and the following week comprise the dietary intervention period. Food is provided by the study team for 7 days in accordance with a low UP diet. Visit 3 and the following week comprise the dietary adherence period, during which all participants receive instructions for a low UP diet to follow on their own. All participants will complete remote assessments at 1 week, 1 month, and 3 month follow-up.
Intervention Type
Other
Intervention Name(s)
Dietary change (high ultra-processed food)
Intervention Description
Visit 1 and the following week comprise the baseline assessment period. Visit 2 and the following week comprise the dietary intervention period. Food is provided by the study team for 7 days in accordance with a high UP diet. Visit 3 and the following week comprise the dietary adherence period, during which all participants receive instructions for a low UP diet to follow on their own. All participants will complete remote assessments at 1 week, 1 month, and 3 month follow-up
Primary Outcome Measure Information:
Title
Withdrawal Symptoms
Description
Withdrawal symptoms (e.g., anger, anxiety) will be assessed using ecological momentary assessment (EMA) on a scale from 1 (not at all) to 7 (extremely); higher scores indicate greater withdrawal symptoms.
Time Frame
Assessed during dietary intervention period for 1 week
Title
Craving of ultra-processed (UP) foods
Description
Craving of UP foods will be assessed using EMA on a scale from 1 (not at all) to 7 (extremely); higher scores indicate greater craving of UP foods.
Time Frame
Assessed during dietary intervention period for 1 week
Title
Low UP food intake
Description
Intake of low UP foods will be assessed using remote food photography method.
Time Frame
Assessed during dietary adherence period for 1 week
Title
Self-Reported Low UP food intake
Description
Intake of low UP foods will be assessed using EMA reports of food intake. Responses will be coded into high and low UP food intake based on the NOVA classification.
Time Frame
Assessed during dietary adherence period for 1 week
Secondary Outcome Measure Information:
Title
Reactivity to a stressor
Description
Stress reactivity will be assessed using an in-lab stress task that has participants listen to an audio recording of a current stressor in their life. Participants' heart rate in response to the audio recording, relative to a baseline measurement, will be used as an indicator of stress reactivity; an increase in heart rate will be indicative of greater stress reactivity.
Time Frame
Assessed post-dietary change during in-lab Visit 3 (1 day)
Title
Self-reported reactivity to a stressor
Description
Stress reactivity will be assessed using an in-lab stress task that has participants listen to an audio recording of a current stressor in their life. Participants' subjective ratings of reactivity will be assessed at baseline (prior to listening to the audio recording) and immediately after listening to the audio recording using the negative affect subscale from the Positive and Negative Affect Schedule (PANAS); each item is rated on a 1 (very slightly or not at all) to 5 (extremely) scale, with higher numbers indicating greater experienced affect; an increase in score, relative to baseline, will indicate greater stress reactivity.
Time Frame
Assessed post-dietary change during in-lab Visit 3 (1 day)
Title
Cue reactivity to a simulated fast food restaurant
Description
Participants will spend 5 minutes in a simulated fast food restaurant. Participants' heart rate in response to the simulated fast food restaurant, relative to a baseline measurement, will be used as an indicator of cue reactivity; increases in will be indicative of greater cue reactivity.
Time Frame
Assessed post-dietary change during in-lab Visit 3 (1 day)
Title
Self-reported cue reactivity to a simulated fast food restaurant
Description
Participants will spend 5 minutes in a simulated fast food restaurant. Participants' subjective craving will be assessed at baseline (prior to entering the restaurant) and while in the restaurant on a scale from 0 (no craving at all) to 100 (I have never craved food more), with greater numbers indicating higher craving; an increase in score, relative to baseline, will indicate greater cue reactivity.
Time Frame
Assessed post-dietary change during in-lab Visit 3 (1 day)
Title
Level of reinforcement value for ultra processed foods
Description
Participants will complete a computerized task that measures their willingness to work (i.e., reinforcement value) for a UP food gift card relative to a non-food gift card.
Time Frame
Baseline assessed during in-lab Visit 1 (1 day); assessed again post-dietary change during in-lab Visit 3 (1 day)
Title
Magnitude of neural reward-related response to tasting a milkshake
Description
Participants will complete an fMRI paradigm where they see a UP food cue (i.e., picture of a chocolate milkshake) that predict receipt of a UP food (i.e., a chocolate milkshake). The paradigm also includes a control cue (i.e., picture of a water glass) that predicts receipt of a tasteless solution (which contains the ionic components of saliva; 25 mM KCl and 2.5 mM NaHCO3 in distilled water). Participants' activation in neural regions associated with reward (e.g., mOFC, striatum) to the milkshake cue (relative to the water cue) will be used as a measure of increased reward-related response to UP food cues.
Time Frame
Assessed post-dietary change during in-lab Visit 3 (1 day)
Title
Blood Glucose Level
Description
Assessed using a continuous blood glucose monitor.
Time Frame
Assessed during dietary adherence period for 1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 25 to 60 years of age English-speaking Must own an Android or iPhone Smartphone Live within a 1-hour radius of the laboratory endorsement of > 4 symptoms on the YFAS 2.0 completed during eligibility screener; at the time of consent, symptom count must remain above threshold for food addiction (this discrepany is based on a previously found tendency during pilot testing to overestimate food addiction symptoms at the time of screening) endorse daily intake of multiple UP foods likes chocolate milkshake (fMRI) willing to follow dietary instructions provided by team willing to come to lab 3 times Exclusion Criteria: participants with a self-reported BMI < 18.5 and > 40 current diagnoses of disorders that can impact reward, metabolic functioning, or the ability to complete the imaging protocol (e.g., seizures, Tourette's, cancer, Irritable bowel syndrome, Inflammatory bowel disease, Hypothyroidism, substance use disorder, ADHD) Type 1 or Type 2 diabetes, pre-diabetes, hypoclycemia history of food allergies or restrictive dietary requirements (e.g., vegan) medications that impact appetite or reward functioning (e.g., anti-psychotic medication, insulin) history of diagnosis of a severe mental illness (e.g., bipolar, schizophrenia, psychotic disorder) a diagnosis of a restrictive eating disorder (anorexia nervosa, bulimia nervosa, purging disorder) within the last 5 years more than a 20-pound weight fluctuation in the last three months prior weight loss surgery (e.g., bariatric surgery) current pregnancy, breast-feeding, trying to get pregnant, or within six months of having given birth high levels of caffeine (i.e., average daily intake over 600mg) intake use of tobacco, nicotine, cannabis products within the past month and/or unwillingness to abstain from these substances during the main portion of the study high-risk alcohol use (based on the AUDIT) high levels of picky eating fMRI contraindications (e.g., claustrophobia, metal implants) red/green color blindness frequent (i.e., weekly) night shift work or irregular shifts and for abnormal sleep patterns (i.e., wake up time after 11am) inability to complete a random report within 90 minutes THC Cannabis within the past week
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ashley Gearhardt, PhD
Phone
734-647-3920
Email
agearhar@umich.edu
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashley Gearhardt, PhD
Phone
734-647-3920
Email
agearhar@umich.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
This research will generate demographic, neural, heart rate, ecological momentary assessment, continuous glucose monitoring, self-report and anthropometric data. The data will be stored as SPSS or SAS files. Meta data will also be included in the selected repositories. The metadata will include the data dictionaries, which describe the generation of all variables. The deidentified data will be made available within one year of completion of the study at the University of Michigan's data repository - Deep Blue.
IPD Sharing Time Frame
Beginning 1 year and ending 7 years following article publication
IPD Sharing Access Criteria
Researchers who provide a methodologically sound proposal will be able to access data to achieve aims outlined in the approved proposal. Proposals should be directed to agearhar@umich.edu to gain access. Data requestors will need to sign a data access agreement.

Learn more about this trial

Ultra Crave: An Investigation of Ultra-Processed Food

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